China Publishes Long-Awaited Management Measures for the Supervision of Toothpaste
On March 23, 2023, the Chinese State Administration for Market Regulation (SAMR) released the long-awaited Management Measures for the Supervision of Toothpaste (“Measures”),[1] which set forth the basic rules that must be followed by toothpaste products manufactured or distributed in China.
Per the Measures, the National Medical Products Administration (NMPA) is responsible for the management of toothpaste in China. As mandated in the Cosmetics Supervision and Administration Regulation (CSAR),[2] the management of toothpaste products follows the regulatory regime for general cosmetics (for more information about the management of cosmetics, you may refer to our CRM - More Make-Up Applied to China’s Management of Cosmetics: Here’s How It Looks). That is to say, toothpaste products must be notified with NMPA before they can be marketed in China. For imported toothpaste products, one must complete the notification procedures and receive a notification number before the product can be imported. One aspect of the notification process is to submit documentation stating that the product is sold in the country of the manufacturer. If the product is not sold in the country of origin and is designed exclusively for export to China, study/test results targeting Chinese consumers must be provided.
The Measures also specify new requirements for toothpaste ingredients. Specifically, the Measures classify them into two categories, i.e., “existing toothpaste ingredients” and “new toothpaste ingredients.” The latter is defined as “natural or artificial raw materials used in toothpaste for the first time in China,” and subject to different pre-market requirements per their intended function (e.g., new preservatives and colorants are subject to ingredient registration). NMPA will establish an inventory of existing toothpaste ingredients, which may serve as the key reference to determine if an ingredient is new for use in toothpaste in China. This inventory is expected to become available in the near future. Notably, the toothpaste manufacturer is responsible for the safety of ingredients that it uses and is required to explain the source and safety of the ingredients in its product notification.
In addition to some labeling specifications, the Measures require that the functionality of toothpaste should be substantiated with scientific proof. A summary of relevant data with regard to the functionality of toothpaste should be made available to the public. A categorization catalogue of toothpaste products will be published by NMPA and adjusted from time to time, based on factors such as the asserted function, targeted user group, etc. Function claims used to promote toothpaste products must be within the limits set forth in pertinent standards and technical protocols. Notably, in 2021, China issued a draft of Norms for Toothpaste Notification,[3] which includes a list of permitted function claims for toothpaste products. It is important for the industry to closely monitor the development of these rules.
The Measures touch upon toothpaste products for children without elaboration on the specific legal documents to follow. We expect that individual administrative regulations, mandatory national standards, and technical specifications will be adopted in the future to regulate this special toothpaste category.
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The new Measures will take effect on December 1, 2023. Should you wish to learn more details about the Measures, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Li (li@khlaw.com), Yin Dai (dai@khlaw.com), or your existing contact at Keller and Heckman LLP.
[1] https://gkml.samr.gov.cn/nsjg/fgs/202303/t20230323_354050.html
[2] https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20200629190501801.html
[3] https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjhzhp/20210106145013118.html